Archives for November 2012

One of the things we come across often in our practice is overly creative positioning of a medical product. In a wish to minimise (or even avoid) a regulatory burden, the client wants to label a product as something it clearly is not. In such circumstances we always ask: “does it look like, walk like and quack like a duck?”

Where is the Life we have lost in living? Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information? Had T. S. Eliot included one further line into his poem, data would have been challenged in a more elegant form than that described by Clifford Stoll taking […]

For medical device manufacturers currently shipping or planning to import products into China, SFDA has now issuedorder 2012-280 (September 2012) urging all non-Chinese manufacturers to comply with the Chinese labelling requirements.

So are you confident that your Chinese labels satisfies SFDA requirements? Are you sure it includes all details that must be specified?

Case Studies

One System, many sites. A US headquartered multi-national implant manufacturer had been marketing in Taiwan for more than ten years and had obtained multiple product approvals based on US FDA approvals. Rapid expansion over that period spanned had enlarged operations to more than 20 separate global manufacturing sites controlled by a single quality system. Taiwan […]